Download ComfortSelect User Manual

Instructions for Use
ComfortSelect Nasal Mask and Premium Headgear
Intended Use
The ComfortSelect Nasal Mask is intended to provide an interface for application of CPAP or
bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use
in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for
whom CPAP or bi-level therapy has been prescribed.
Important Note: An exhalation port is built into the ComfortSelect Nasal Mask so a
separate exhalation port is not required.
Caution: U.S. federal law restricts this device to sale by or on the order of a physician.
Symbols
Warning or
Caution
Note
Does not contain
natural rubber latex
Tip
Consult instructions
for use
System One Resistance
Control Setting
Warnings:
•• This mask is not suitable for providing life support ventilation.
•• This mask is designed for use with CPAP or bi-level systems recommended by your health
care professional or respiratory therapist. Do not wear this mask unless the CPAP or bi-level
system is turned on and operating properly. Do not block or try to seal the exhalation port.
Explanation of the Warning: CPAP systems are intended to be used with special masks with
connectors which have vent holes to allow continuous flow of air out of the mask. When the
CPAP machine is turned on and functioning properly, new air from the CPAP machine flushes
the exhaled air out through the attached mask exhalation port. However, when the CPAP
machine is not operating, enough fresh air will not be provided through the mask, and exhaled
air may be rebreathed. This warning applies to most models of CPAP systems. Rebreathing of
exhaled air for longer than several minutes can, in some circumstances, lead to suffocation.
•• If oxygen is used with the device, the oxygen flow must be turned off when the device is not
operating. Explanation of the Warning: When the device is not in operation, and the oxygen
flow is left on, oxygen delivered into the ventilator tubing may accumulate within the device
enclosure. Oxygen accumulated in the device enclosure will create a risk of fire.
•• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence
of an open flame.
•• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary,
depending on the pressure settings, patient breathing pattern, mask selection, and the leak
rate. This warning applies to most types of CPAP and bi-level machines.
•• Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue
use and contact your healthcare professional.
•• At low CPAP or EPAP pressures, the flow through the exhalation port may be inadequate to
clear all exhaled gas from the tubing. Some rebreathing may occur.
•• Hand wash prior to first use. Inspect the mask for damage or wear (cracking, crazing, tears,
etc). Discard and replace any components as necessary.
•• Use of a nasal or full face mask may cause tooth, gum, or jaw soreness or aggravate an existing
dental condition. Consult your physician or dentist if symptoms occur.
•• If an additional exhalation device is added to the patient circuit, you may need to adjust the
pressure level to compensate for the additional leak of the exhalation device.
1
Cleaning Instructions
Hand wash the mask before first use and daily. The headgear should be hand washed weekly, or
as needed. The headgear does not need to be removed for daily cleaning of the mask.
1. Hand wash the mask and headgear in warm water with a mild liquid dish washing
A
detergent (Figure 2).
Caution: Do not use bleach, alcohol, cleaning solutions
B
containing bleach or alcohol, or cleaning solutions containing
conditioners or moisturizers.
C
E
2. Rinse thoroughly with drinking quality water and air dry out of
direct sunlight. Make sure the mask is dry before use. Lay the
headgear flat or line dry. Do not place the headgear into the
dryer.
D
3. Inspect all parts for damage or wear; replace any parts that
Figure
1
have visibly deteriorated (cracking, crazing, tears, etc). Replace
the mask if the cushion becomes hardened.
A = Forehead Support
For multi-patient use in the hospital/institutional environment,
B = Forehead Support Arm
use the Mask Cleaning and Disinfection Instructions to reprocess C = Exhalation Port
(Do not block)
the mask between patients. These instructions can be obtained by
visiting www.sleepapnea.com or contacting Customer Service at D = Swivel
E= Swivel Clip
1-800-345-6443 (USA or Canada) or 1-724-387-4000.
System One Resistance Control
This mask uses the System One Resistance Control setting
. This symbol may
appear on your therapy device. This symbol represents the level of mask resistance
compensation. Match the setting to the mask if appropriate.
Important Notes:
•• Verify the System One setting if the mask or mask cushion changes.
•• The System One setting is not compatible with masks requiring a separate/additional
exhalation device.
If your provider has locked the resistance compensation setting, you can view the setting but
cannot change it, and the screen will display a lock symbol. If your provider has disabled the
resistance compensation, you will not see this setting.
Achieving the Right Fit
1. Hold the mask cushion gently over your nose. If the forehead support does not
rest comfortably against your forehead, press the ridged sides at the bottom of the
support arm, and slide the arm up or down the bar until the arm is in a position that is
comfortable for you.
B
2. Slide the headgear over your head. You may want to
disconnect one of the swivel clips before putting on the
headgear. Reconnect the swivel clip after you have the
A
headgear in position.
3. Connect the flexible tubing (included with your CPAP or bilevel device) to the swivel on the mask (Figure 2).
C
4. Turn on the airflow.
5. Lie down and breathe normally through your nose, keeping
Figure 2
your lips closed. You may need to adjust the forehead support
arm to reduce leaks or reduce pressure points at the bridge or
A = Exhalation device
above the lip.
(Do not block)
6. Loosen the EZPeel tabs to unhook the straps and gradually
B = Premium headgear with
tighten them until the mask has minimal leaks and fits
EZPeel tabs
comfortably.
C = Flexible tubing (to device)
2
Removing the Mask and Headgear
You can disconnect the headgear from the mask in the following ways:
1. Disconnect the forehead support by pressing on the center of the forehead support and
then gently pressing the sides of the forehead support arm together (Figure 3).
2. Disconnect the neck straps by removing the swivel clips from their sockets (Figure 4).
3. Slide the headgear over your head. The entire headgear stretches (Figure 5).
Figure 3
Figure 4
Figure 5
Cushion Removal and Reattachment
1. Remove the cushion by detaching its retaining ring from the faceplate. Do this by
unhooking the side and bottom clips of the ring from their connection points on the
faceplate. Take the ring off of the cushion. Clean or discard the cushion if necessary.
2. Place the cleaned or new cushion on the faceplate, making sure that the two slits at the
bottom of the cushion catch on and fit securely into the two tabs at the bottom of the
faceplate.
3. Place the retaining ring around the cushion.
4. Connect the ring clips to the faceplate, starting with the top clip. Push the retaining ring
into the faceplate until you hear a clicking sound.
Note: Make sure the lines on the bottom of the faceplate, cushion, and retaining ring are
all aligned when assembled.
Forehead Pad Replacement
If you need to replace the forehead pad, contact your
home care provider to reorder. Follow the instructions
below (Figure 6).
1. Remove the pad. Slide the pad outward toward one
edge of the forehead support, and lift it upward so
the connection track on that side is released from
the plastic connection slot. Next, pull the pad in the
opposite direction to release the connection track on
the other side from its connection slot.
2. Install the new pad. Slide one of the connection tracks on the
new pad into its connection slot on the support. Pull the pad
in the opposite direction (toward the center) and slide the
connection track into its connection slot to lock the pad into
place.
Note: Replace the cushion and forehead pad if damaged,
deformed, or hardened.
A
E
B
C
D
Figure 6
A = Connection Point for Clip
B = Faceplate
C = Cushion
D = Retaining Ring
E = Clip
Comfort Tips
•• Clean your face and mask thoroughly before each use.
•• Make sure the mask is the correct size for your face.
•• Do not overtighten the headgear. Overtightening can irritate your face, increase leaks, or
cause damage to the mask.
•• Replace the cushion and forehead pad if they become hardened or deformed.
3
Disposal
Dispose of in accordance with local regulations.
Specifications
Warning: The technical specifications of the mask are provided for your healthcare
professional to determine if it is compatible with your CPAP or bi-level therapy device. If
used outside these specifications, or if used with incompatible devices, the mask may be
uncomfortable, the seal of the mask may not be effective, optimum therapy may not be
achieved, and leak, or variation in the rate of leak, may affect device function.
Intentional Leak
70
60
50
40
30
20
10
0
Pressure Drop cm H 20 (hPa)
50 SLPM
All cushion 0.1
sizes: S, M, SW
0
4
8
12
16
100 SLPM
0.2
Deadspace
S 119 cc
M 129 cc
SW 128 cc
20
Storage Conditions
Temperature: -4° F to +140° F (-20° C to +60° C)
Relative Humidity: 15% to 95%, non-condensing
Reorder Numbers
Part #
Description
Part #
Description
1002800
Deluxe Headgear
1018401
Forehead Support and Pad
1007933
ComfortSelect Mask, S
1009722
Silicone Forehead Pads, 4 pack
1007932
ComfortSelect Mask, M
1009723
Headgear Swivel Clips, 2 pack
1007934
ComfortSelect Mask, Small Wide 1008814
ComfortSelect Retaining Ring
1007930
ComfortSelect Mask w/hgr, S
1004395
Exhalation Elbow Kit
1007919
ComfortSelect Mask w/hgr, M
1002720
Split Washer Kit, 5 each
1007931
ComfortSelect Mask w/hgr,
Small Wide
7041
Mask Swivel
1007936
ComfortSelect Cushion, S
312710
O2 Enrichment Attachment
1007935
ComfortSelect Cushion, M
1007937
ComfortSelect Cushion, Small
Wide
Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 USA
4
1067720
JDH 3/29/10
© 2010 Koninklijke Philips Electronics N.V. All rights reserved.